By Susan Comninos
NEW YORK (Reuters Health) – Sepracor Inc. on Thursday said that its asthma drug Xopenex (levalbuterol) has gained an additional indication for use in children ages 6 to 11.
The US regulatory decision will allow it to sell Xopenex for pediatric use in a nebulizer at dosage strengths of 0.31 mg and 0.63 mg, Sepracor said. The drug is already sold in the US in doses of 0.63 mg and 1.25 mg asthmatics ages 12 and older.
Sepracor 's supplemental application for the drug included data comparing Xopenex inhalation solution at the pediatric doses with racemic albuterol inhalation solution at 1.25 mg and 2.5 mg dosages in patients with mild-to-moderate asthma, the firm said.
Researchers found the new pediatric doses to be safe and effective in children ages six and older, according to lead investigator Dr. Henry Milgrom, based at the National Jewish Medical and Research Center. The drug's broadened label "provides an opportunity to treat children with asthma effectively with a child-sized dose of the drug," he added.
The study was published in the December 2001 issue of the Journal of Allergy and Clinical Immunology.
Recommended dosing of Xopenex in the pediatric group is 0.31 mg thrice-daily, Sepracor said, and regular dosing of the drug should not surpass 0.63 mg thrice-daily.
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